Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures
Information source: Fundación Universitaria de Ciencias de la Salud
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Remifentanil (Drug); Propofol (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Fundación Universitaria de Ciencias de la Salud Official(s) and/or principal investigator(s): Luis A Muñoz, MD, Study Director, Affiliation: Fundacion Universitaria de Ciencias de la Salud Luis E Reyes, MD, Principal Investigator, Affiliation: Fundacion Universitaria de Ciencias de la Salud
Summary
The purpose of this study was to compare remifentanil and propofol for sedation of patients
during endoscopic gastrointestinal procedures.
Clinical Details
Official title: Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Patient satisfaction
Secondary outcome: Gastroenterologist satisfactionAdverse events
Detailed description:
The administration of sedation with target controlled infusion (TCI) systems could offer a
safe alternative for the management of discomfort of patients undergoing endoscopic
gastrointestinal procedures. However, what medication from those available for TCI would be
the most appropriate is not known.
Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned
to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary
outcome was patient satisfaction. Secondary outcomes included gastroenterologist
satisfaction, the proportion of adverse events between the two groups were compared
(occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory
depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and
the level of consciousness.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at
Hospital de San Jose, Bogota, between January and December 2010.
- Be between 18 and 70 years old.
- American Society of Anesthesiology Physical Status classification between 1 and 3.
- Provide written informed consent.
Exclusion Criteria:
- Patients with difficult airway indicators.
- Pregnant women.
- Patients with chronic pain.
- Chronic opioid or benzodiazepine users (>3 months).
- Allergy history to remifentanil or propofol or eggs.
- Psychoactive drug users.
- Smokers (> 5 cigarettes per day in the previous 3 months).
- Body mass index > 30.
Locations and Contacts
Fundación Universitaria de Ciencias de la Salud, Bogota 11001000, Colombia
Additional Information
Starting date: January 2010
Last updated: December 8, 2012
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